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Development and implementation of the National Heart, Lung, and Blood Institute COVID-19 common data elements
Alexandra Weissman1, Alex Cheng2, Alex Mainor2
1Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Insights
The National Heart, Lung, and Blood Institute developed COVID-19 Common Data Elements (CDEs) to standardize clinical research data. These CDEs facilitate data pooling and analysis for better understanding of the pandemic.
Area of Science:
- Medical Research
- Clinical Trials
- Data Standardization
Background:
- The rapid onset of Coronavirus Disease 2019 (COVID-19) led to swift clinical research, initially lacking standardized data collection.
- This lack of standardization hindered the potential for pooling data from various studies.
- The National Heart, Lung, and Blood Institute (NHLBI) initiated efforts to address this data harmonization gap.
Purpose of the Study:
- To develop a concise set of Common Data Elements (CDEs) for COVID-19 clinical research.
- To facilitate data standardization and pooling across emerging studies.
- To support regulatory submission and data sharing.
Main Methods:
- An iterative development approach guided by three principles: leveraging existing multi-center COVID-19 trials, incorporating existing data standards, and aligning with standards for data sharing and regulatory submission.
- Rapid implementation of CDEs in NHLBI-funded studies.
- Iterative refinement of CDEs based on feedback from study teams.
Main Results:
- The NHLBI COVID-19 CDEs are publicly available and currently utilized in COVID-19 clinical trials.
- CDEs are organized into domains and prioritized using a three-tiered system.
- The CDE manual, data dictionary, and implementation guidance are accessible online.
Conclusions:
- The developed CDEs aid data harmonization, enabling pooled analyses for COVID-19 research.
- The guiding principles facilitated focused development and adaptation to evolving COVID-19 knowledge.
- The CDEs have the potential for generalization to other acute respiratory illnesses.
Background:
Coronavirus Disease 2019 (COVID-19) instigated a flurry of clinical research activity. The unprecedented pace with which trials were launched left an early void in data standardization, limiting the potential for subsequent data pooling. To facilitate data standardization across emerging studies, the National Heart, Lung, and Blood Institute (NHLBI) charged two groups with harmonizing data collection, and these groups collaborated to create a concise set of COVID-19 Common Data Elements (CDEs) for clinical research.
Methods:
Our iterative approach followed three guiding principles: 1) draw from existing multi-center COVID-19 clinical trials as precedents, 2) incorporate existing data elements and data standards whenever possible, and 3) alignment to data standards that facilitate data sharing and regulatory submission. We also supported rapid implementation of the CDEs in NHLBI-funded studies and iteratively refined the CDEs based on feedback from those study teams.
Results:
The NHLBI COVID-19 CDEs are publicly available and being used for current COVID-19 clinical trials. CDEs are organized into domains, and each data element is classified within a three-tiered prioritization system. The CDE manual is hosted publicly at https://nhlbi-connects.org/common_data_elements with an accompanying data dictionary and implementation guidance.
Conclusions:
The NHLBI COVID-19 CDEs are designed to aid data harmonization across studies to achieve the benefits of pooled analyses. We found that organizing CDE development around our three guiding principles focused our efforts and allowed us to adapt as COVID-19 knowledge advanced. As these CDEs continue to evolve, they could be generalized for use in other acute respiratory illnesses.
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